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. 2017 Jun 22;2017(6):CD007419. doi: 10.1002/14651858.CD007419.pub5
Methods Prospective study, treatment in the better‐seeing eye
Participants Country: Turkey
Number of people randomised: 70 participants (35 ranibizumab, 35 grid laser)
Average age: 64.6 ± 8.2 years ranibizumab; 63.8 ± 7.4 years laser
Sex: 21% male ranibizumab, 18% male laser
Inclusion criteria:
  • evidence of CSME by means of FFA

  • at least 6 months of follow‐up

  • no other systemic or ocular disease that might affect vision


Exclusion criteria:
  • participants with a history of intravitreal injection and laser photocoagulation for proliferative diabetic retinopathy or CSME

  • participants with vitreous haemorrhage present at the time of recruitment or vitreous haemorrhage which developed after enrolment

Interventions Focal or grid laser photocoagulation treatment was performed in 35 participants and laser settings, including power, spot size, duration and number of burns, were recorded
35 participants received initial injection of ranibizumab 0.5 mg/0.05 mL. All participants of both groups received treatment in their better‐seeing eye. After the induction phase, the intravitreal injections were administered if any of the following changes were observed: presence of visual acuity loss; persistent or recurrent subretinal or intraretinal fluid.
Outcomes Group comparisons of absolute scores and mean changes from baseline scores at 6‐month visit were performed using analysis of the Turkish version of VFQ‐25; it has modifications to adjust for Turkish culture and lifestyle.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No data available
Allocation concealment (selection bias) Unclear risk No data available
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No data available
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No data available
Incomplete outcome data (attrition bias) All outcomes Low risk No loss to follow‐up reported
Selective reporting (reporting bias) Unclear risk No specific statement nor protocol available
Other bias Low risk No other bias identified
Overall risk of bias Unclear risk Most items not reported